Consumer Information for: ACT REPAGLINIDE
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
ACT REPAGLINIDE is used:
- To lower blood sugar in patients with type 2 diabetes mellitus whose blood sugar levels cannot be controlled by diet and exercise alone (monotherapy)
- In combination with metformin to lower blood sugar in patients whose blood sugar levels cannot be controlled by diet and exercise only plus metformin alone.
- In combination with rosiglitazone in patients who cannot take metformin and whose blood sugar levels cannot be controlled by diet and exercise plus ACT REPAGLINIDE or rosiglitazone alone.
What it does
ACT REPAGLINIDE is an oral anti-diabetic agent used for the treatment of diabetes mellitus. It helps your body release more insulin when your blood sugar is high. This helps improve your blood sugar control.
When it should not be used
Do not use ACT REPAGLINIDE if you:
- Have a known hypersensitivity to repaglinide tablets or any of the other ingredients in ACT REPAGLINIDE
- Have diabetic ketoacidosis (accumulation of ketones in the blood and urine).
- Have type 1 diabetes.
- Have severe liver disease.
- Are taking gemfibrozil (a medicine used to lower increased fat levels in the blood).
- Are taking clopidogrel (a medicine used to prevent blood clots).
What the medicinal ingredient is
repaglinide
What the non-medicinal ingredients are
Calcium hydrogen phosphate, croscarmellose sodium, glycerol, iron oxide red (2 mg tablet only), iron oxide yellow (1 mg tablet only), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, poloxamer and povidone.
What dosage form it comes in
0.5 mg, 1 mg, 2 mg Tablets are available d bottles of 100 tablets.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to you healthcare professional before you take ACT REPAGLINIDE. Talk about any health conditions or problems you may have, including if you:
- Have a history of allergy or intolerance to any medications or other substances
- Have a history of liver or kidney problems
- Are or think you may be pregnant
- Are breastfeeding
- Are over 75 years of age
Other warnings you should know about
ACT REPAGLINIDE is not recommended for use in children and adolescents less than 18 years of age.
The treatment with insulin secretagogues (drugs that stimulate insulin secretion from the pancreas) in general has been associated with more heart-related deaths as compared to treatment with diet alone or diet plus insulin.
ACT REPAGLINIDE may cause low blood sugar (hypoglycemia), especially if you miss a meal, exercise for a long time, drink alcohol or use another anti-diabetic medication with ACT REPAGLINIDE.
You should ask your doctor or pharmacist or diabetes educator about symptoms of low blood sugar and what to do if you experience these symptoms. You should also test your blood sugar as instructed by your doctor.
The warnings signs of hypoglycemia may come on suddenly and can include:
- cold sweat
- cool pale skin
- headache
- rapid heart beat
- feeling sick
- difficulty in concentrating
Severe hypoglycemia can cause loss of consciousness, seizure, brain damage and even death.
Your blood sugar may get too high (hyperglycemia) if you have fever, infection, surgery or trauma (stress conditions). In such cases, contact your doctor as your medication may need to be adjusted.
Driving and Operating Machinery
Alertness and reactions may be impaired due to low blood sugar (hypoglycemia), especially when beginning or changing treatment or when ACT REPAGLINIDE is not taken regularly. This may affect you ability to drive or to operate machinery.
Interactions with this medication
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions
Do not use ACT REPAGLINIDE (repaglinide) with gemfibrozil (used to treat high blood fats).
Do not use ACT REPAGLINIDE (repaglinide) with clopidogrel (a medicine used to prevent blood clots).
Many medicines affect the way glucose works in your body and this may influence your ACT REPAGLINIDE dose. Listed below are the most common medicines which may affect your treatment with ACT REPAGLINIDE:
- Other anti-diabetic agents (used to lower blood sugar)
- Monoamine oxidase inhibitors (used to treat depression)
- Beta-blocking agents (used to treat high blood pressure and certain heart conditions)
- Angiotensin converting enzyme (ACE)-inhibitors (used to treat high blood pressure and certain heart conditions)
- Salicylates (e.g. acetylsalicylic acid)
- Octreotide
- Non-steroidal anti-inflammatory agents (NSAIDS) (a type of painkiller)
- Anabolic steroids and corticosteroids (used for anemia or to treat inflammation)
- Oral contraceptives (used for birth control)
- Thiazides (diuretics or ‘water pills’)
- Danazol (used to treat breast cysts and endometriosis)
- Thyroid hormones (used to treat patients with low levels of thyroid hormones)
- Sympathomimetics (used to treat asthma)
- Clarithromycin, trimethoprim, rifampicin (antibiotics)
- Itraconazole, ketoconazole (anti-fungal drug)
- Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy/seizures)
- Cyclosporine (used to supress the immune system)
- Deferasirox (used to reduce chronic iron overload)
- Non-prescription and over the counter drugs such as drugs for appetite control, asthma, colds, cough, hay fever or sinus problems.
Alcohol may increase the effect of ACT REPAGLINIDE on lowering your blood sugar and therefore impair you ability to concentrate. Avoid drinking alcohol while you are taking ACT REPAGLINIDE.
Grapefruit juice may increase the effect of ACT REPAGLINIDE.
Proper use of this medication
How to take ACT REPAGLINIDE:
Your doctor will prescribe ACT REPAGLINIDE according to your needs. Take ACT REPAGLINIDE exactly as prescribed by your doctor.
Usual Dose
ACT REPAGLINIDE tablets should be taken with meals, usually 15 minutes before the meal. However, ACT REPAGLINIDE tablets may be taken 30 minutes before a meal or right before a meal.
Overdose
If you take more ACT REPAGLINIDE than you should, your blood sugar may become too low leading to a hypoglycemic event.The symptoms of such an event include: headache, dizziness, tiredness, rapid heartbeat, nervousness, shakiness, nausea and sweating.
Discuss with your healthcare professional about how to treat low blood sugar.
If you think you have taken too much ACT REPAGLINIDE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you miss a dose of ACT REPAGLINIDE do not take the missed dose. Wait and take your usual dose before your next meal.
Side effects and what to do about them
What are the possible side effects from using ACT REPAGLINIDE?
These are not all the possible side effects you may feel when taking ACT REPAGLINIDE. If you experience any side effects not listed here, contact your healthcare professional. Please also see WARNINGS AND PRECAUTIONS.
The following side effects may occur during your treatment with ACT REPAGLINIDE:
Common
- Visual disturbance
- Abdominal pain
- Nausea
- Constipation
Uncommon
- Liver dysfunction
- Itching
- Redness
- Vomiting
- Rash
- Hives
- Abnormal blood test results
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Very Common | |||
| Low blood sugar
(hypoglycemia) Symptoms include: cold sweat, cool pale skin, headache, rapid heartbeat, feeling sick and/or difficulty in concentrating. |
✔ | ||
| Common | |||
| High blood sugar (hyperglycemia) Symptoms include: increased urination, feeling thirsty, dry skin and dry mouth. |
✔ | ||
| Sudden severe headache or worsening of headache, dizziness, tremors, fatigue or increased sweating | ✔ | ||
| Diarrhea, constipation, gas, upset stomach, nausea or abdominal pain | ✔ | ||
| Sudden partial or complete loss of vision | ✔ | ||
| Uncommon | |||
| Chest pain or pressure, and/or shortness of breath | ✔ | ||
| Allergy Symptoms include: swelling, difficulty breathing, rapid heartbeat, feeling dizzy and sweating. |
✔ | ||
If you have troublesome symptom or side effects that is not listed here or becomes bad enough to interfere with your daily activities, talk to you healthcare professional.
This is not a complete list of side effects. For any unexpected effects while taking ACT REPAGLINIDE, contact your doctor or pharmacist.
How to store
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found by contacting the
Teva Canada Limited by:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Last revised: April 3, 2020
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